MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. TOWEL,OR,DSP,ST,BLUE,STD,6/PK,12PK/CS; DRAPE, SURGICAL

Model Number	MDT2168286
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Opened product case to restock.Found an unknown liquid within the plastic liner of the case where the product is.

• Brand Name: TOWEL,OR,DSP,ST,BLUE,STD,6/PK,12PK/CS
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 15378246
• Report Number: 15378246
• Device Sequence Number: 17597581
• Product Code: KKX
• UDI-Device Identifier: 20080196282743
• UDI-Public: (01)20080196282743
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2022
• Report Date (Section F): 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MDT2168286
• Device Catalogue Number: MDT2168286
• Device Lot Number: 6052204021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/06/2022